Office of the Provost

Principles and Guidelines for Recipients of NIH Research Grants and Contract

M E M O R A N D U M

TO: University Research Community

FROM: George E. Klinzing Vice Provost for Research

DATE: October 2, 2000

SUBJECT: Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources

The National Institutes of Health ("NIH") recently issued Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090) ("Principles"). These Principles were issued by NIH to provide guidance and direction to NIH funding recipient institutions to balance the need to protect intellectual property rights with the need to broadly disseminate new discoveries. This memo is to call attention to the issues cited in the Principles and to ask for your help in ensuring our compliance. A copy of the complete Principles can be obtained at the NIH web site: www.nih.gov/od/ott/RTguide_final.htm

The Principles apply to all NIH-funded entities, and it is particularly important that they be communicated to investigators and persons who assist with material transfer agreements. The Principles apply specifically to biomedical research tools, which are broadly defined to include cell lines, monoclonal antibodies, reagents, animal models, combinatorial chemistry libraries, clones and cloning tools, databases and software (under some circumstances).

The Principles were developed in response to complaints from researchers that restrictive terms in material transfer agreements were impeding the sharing of research resources. These restrictions came both from industry sponsors, and less frequently, from research institutions. The NIH urges recipient institutions to adopt policies and procedures to encourage the exchange of research tools. This memo summarizes the steps the University is taking to implement the Principles.

There are four major points that the Principles address.

1. Minimizing administrative impediments to the exchange of biomedical research tools.

The University has followed the Principles to develop a simple Material Transfer Agreement letter to be used in the transfer of biomedical research tools developed at the University to third parties for research purposes. There are two forms of this letter: one for nonprofit institutions and another for commercial firms. These forms, copies of which are attached and are also available on the Office of Research web site (www.pitt.edu/~offres/proposal/mta_intro.html), should be used by investigators who wish to transfer biomedical resources to third parties. In certain cases, a more stringent letter for a Material Transfer Agreement may be warranted, and the researcher is advised to check with the Office of Research and the Office of Technology Management if any questions arise as to the appropriate format.

2. Ensuring academic freedom and timely disclosure of research findings.

Delays in publication can hinder the advancement and dissemination of knowledge and as such, can be both costly and detrimental to the University's mission. It is the responsibility of researchers to publish their results so that the research community can learn of important findings that advance the frontiers of knowledge to the benefit of all. The Principles make clear that Aexcessive publication delays or requirements for editorial control, approval of publications, or withholding of data all undermine the credibility of research results and are unacceptable. When dealing with commercial firms, the University of Pittsburgh is careful to emphasize that it does not do secret research. Similarly, in negotiating contracts with these firms, the Office of Research and the Office of Technology Management are scrupulous in insisting that research results are free to be published. Short delays in publication (of no more than 60 days) are permitted to enable the sponsor's review of material deemed proprietary. Further delay to seek patent protection may be accommodated, but the total delay period should not exceed 180 days. Investigators must not accept terms from sponsors that unduly limit the right publish research results.

3. Ensuring appropriate implementation of the Bayh-Dole Act.

Under the Bayh-Dole Act, the Office of Technology Management ("OTM") is responsible for reporting to the federal government on inventions that have been developed by the University with any federal funding support. The researcher must disclose to OTM the details of the financial support that was used in developing an invention so that accurate records can be transmitted to the federal government. Title to such inventions is vested in the University, and the Bayh-Dole Act places responsibility on the University to promote the commercialization of the invention. Where the invention is primarily a research tool, the Principles discourages patenting and exclusive licensing.

Where a biomedical research tool has been patented, a wide distribution on a nonexclusive license basis is encouraged. OTM and the Office of General Counsel will prepare these licenses in compliance with both University and government policies and procedures. OTM has the institutional responsibility for negotiation and management of the licenses that result from the intellectual property of the researcher.

4. Ensuring dissemination of research resources developed with NIH funds.

Researchers often are funded from multiple sources, including NIH funds and funds from industrial sponsors. Industrial sponsors may request terms that conflict with the NIH Principles. The NIH urges recipient institutions to share the Principles with such sponsors to ensure that biomedical research tools may be broadly disseminated.

Your cooperation in sharing these new Principles will help the University in carrying out its research mission. Please be aware that research tools obtained or derived from human tissues may be subject to further restriction to ensure compliance with informed consent restrictions. Any questions concerning such research tools may be addressed to the Institutional Review Board.